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Comparison Between the Effects of High Doses Statin on Ventricular Remodeling in STEMI Patients

Primary Purpose

ST-segment Elevation Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Rosuvastatin 20 mg ,40 mg
Atorvastatin 40mg,80mg
Sponsored by
Damanhour University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-segment Elevation Myocardial Infarction focused on measuring Statin, remodeling, STEMI

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Electrocardiogram showed abnormal elevation of the ST segment. First myocardial infarction occurred. The patients received one-stage percutaneous coronary intervention (PCI) therapy within 12 h. Exclusion Criteria: Severe cardiac insufficiency. Hepatic insufficiency (continuous increase of serum transaminase more than 3 times of the upper limit of normal level). Renal insufficiency (creatinine clearance rate <30 mL/min). Addition of others blood lipid lowering and antioxidant drugs during follow up period. Familial hypercholesterolemia. Malignant tumor. Immune system disease. Acute infectious disease. Hypersensitivity to rosuvastatin and Atorvastatin.

Sites / Locations

  • Damanhour University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Rosuvastatin group

Atorvastatin group

Arm Description

patients will receive Rosuvastatin orally (20-40 mg) at night once daily

patients will receive Atorvastatin orally (40-80 mg) at night once daily

Outcomes

Primary Outcome Measures

Evaluation of the effect on ventricular remodeling
Echocardiogram will be obtained and monitoring the change in echocardiogram indexes.

Secondary Outcome Measures

Full Information

First Posted
October 11, 2022
Last Updated
June 6, 2023
Sponsor
Damanhour University
Collaborators
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05895123
Brief Title
Comparison Between the Effects of High Doses Statin on Ventricular Remodeling in STEMI Patients
Official Title
Comparative Study Between the Effects of High Doses Rosuvastatin and Atorvastatin on Ventricular Remodeling in Patients With ST-Segment Elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damanhour University
Collaborators
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
STEMI is a serious type of coronary heart disease, which is a major cause of disability and death. Morphologically the key feature of remodeling is myocyte hypertrophy, myocyte loss from necrosis or apoptosis, as well as interstitial cell growth especially fibroblast proliferation leading to myocardial fibrosis . Elevated serum LDL-cholesterol concentrations play a proatherogenic role by stimulating inflammation and oxidative processes. Statins have been documented to retard fibrosis and ventricular hypertrophy by the cessation of myofibroblast activity. Clinical studies have proven that statins not only regulate lipids but also improve myocardial fibrosis, regulate cell proliferation and apoptosis, regulate ventricular remodeling, and protect the myocardium
Detailed Description
Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University. All participants should agree to take part in this clinical study and will provide informed consent. (80) patients diagnosed with STEMI will be enrolled from Alexandria university hospital. Serum samples will be collected from patients at the time of admission for measuring the biomarkers. Echocardiogram also will be obtained at the time of admission. All enrolled patients will be divided into two group to receive either Atorvastatin (40-80 mg) or Rosuvastatin (20-40mg). All patients will be followed up during 3 months' period. At the end of 3 months, Serum samples will be collected from patients for measuring the biomarkers and Echocardiogram will be repeated. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. Results, conclusion, discussion, and recommendations will be given.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-segment Elevation Myocardial Infarction
Keywords
Statin, remodeling, STEMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rosuvastatin group
Arm Type
Experimental
Arm Description
patients will receive Rosuvastatin orally (20-40 mg) at night once daily
Arm Title
Atorvastatin group
Arm Type
Experimental
Arm Description
patients will receive Atorvastatin orally (40-80 mg) at night once daily
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 20 mg ,40 mg
Other Intervention Name(s)
cholerose
Intervention Description
patients will receive one tablet rosuvastatin 20-40 mg every night
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 40mg,80mg
Other Intervention Name(s)
ator
Intervention Description
patients will receive one tablet Atorvastatin 20-40 mg every night
Primary Outcome Measure Information:
Title
Evaluation of the effect on ventricular remodeling
Description
Echocardiogram will be obtained and monitoring the change in echocardiogram indexes.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Electrocardiogram showed abnormal elevation of the ST segment. First myocardial infarction occurred. The patients received one-stage percutaneous coronary intervention (PCI) therapy within 12 h. Exclusion Criteria: Severe cardiac insufficiency. Hepatic insufficiency (continuous increase of serum transaminase more than 3 times of the upper limit of normal level). Renal insufficiency (creatinine clearance rate <30 mL/min). Addition of others blood lipid lowering and antioxidant drugs during follow up period. Familial hypercholesterolemia. Malignant tumor. Immune system disease. Acute infectious disease. Hypersensitivity to rosuvastatin and Atorvastatin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeinab M Elhadad, bachelor
Organizational Affiliation
demonstrator of Clinical Pharmacy, Damanhour University.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amira B Kassem, PhD
Organizational Affiliation
Lecturer of Clinical Pharmacy, Damanhour University.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed salahaldin, PHD
Organizational Affiliation
Lecturer of biochemisrty, Damanhour University.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
noha ahmad, PHD
Organizational Affiliation
Lecturer of Clinical Pharmacy, Damanhour University.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
ahmad alamrawy, PHD
Organizational Affiliation
Lecturer of cardiology , Faculty of medicine, Alexandria University.
Official's Role
Study Chair
Facility Information:
Facility Name
Damanhour University
City
Damanhūr
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26311995
Citation
Khurana S, Gupta S, Bhalla H, Nandwani S, Gupta V. Comparison of anti-inflammatory effect of atorvastatin with rosuvastatin in patients of acute coronary syndrome. J Pharmacol Pharmacother. 2015 Jul-Sep;6(3):130-5. doi: 10.4103/0976-500X.162011.
Results Reference
background
PubMed Identifier
10869273
Citation
Sutton MG, Sharpe N. Left ventricular remodeling after myocardial infarction: pathophysiology and therapy. Circulation. 2000 Jun 27;101(25):2981-8. doi: 10.1161/01.cir.101.25.2981. No abstract available.
Results Reference
background
PubMed Identifier
15638784
Citation
Reddy R, Chahoud G, Mehta JL. Modulation of cardiovascular remodeling with statins: fact or fiction? Curr Vasc Pharmacol. 2005 Jan;3(1):69-79. doi: 10.2174/1570161052773915.
Results Reference
background
PubMed Identifier
32626540
Citation
Berezin AE, Berezin AA. Adverse Cardiac Remodelling after Acute Myocardial Infarction: Old and New Biomarkers. Dis Markers. 2020 Jun 12;2020:1215802. doi: 10.1155/2020/1215802. eCollection 2020.
Results Reference
background
PubMed Identifier
28286377
Citation
Neri M, Riezzo I, Pascale N, Pomara C, Turillazzi E. Ischemia/Reperfusion Injury following Acute Myocardial Infarction: A Critical Issue for Clinicians and Forensic Pathologists. Mediators Inflamm. 2017;2017:7018393. doi: 10.1155/2017/7018393. Epub 2017 Feb 13.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7520152/
Description
Luo R, Sun X, Shen F, Design BH-D, Development undefined, 2020 undefined. Effects of High-Dose Rosuvastatin on Ventricular Remodelling and Cardiac Function in ST-Segment Elevation Myocardial Infarction. ncbi.nlm.nih.gov [Internet]. [cited 2021 Aug 20];
URL
https://www.mdpi.com/898930
Description
Bostan M, Stătescu C, Anghel L, Biomolecules I Șerban-, 2020 undefined. PostMyocardial Infarction Ventricular Remodeling Biomarkers-The Key Link between Pathophysiology and Clinic. mdpi.com [Internet]. [cited 2021 Aug 22];
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/
Description
Węgiel M, Interwencyjnej TR-P w K, 2021 undefined. Circulating biomarkers as predictors of left ventricular remodeling after myocardial infarction. ncbi.nlm.nih.gov [Internet]. [cited 2021 Sep 8];

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Comparison Between the Effects of High Doses Statin on Ventricular Remodeling in STEMI Patients

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